Totally Implantable Artificial Lung: Studies for FDA

描述(由申请人提供)： 在NIH SBIR赠款计划(5R44HL53168)的大力支持下，MC3成功地开发了一种名为生物肺(R)的人工肺。生物肺(R)的设计是基于我们的专利、超低压力降人工肺技术。这种设备在过去10年的开发过程中经过了广泛的台式和动物测试，并将以商业形式生产，准备在2004年8月进入美国和欧洲的监管程序。考虑到美国广泛且昂贵的监管程序，MC3认为，通过与医疗器械分销商签订许可协议，获得FDA的研究设备豁免(IDE)是必要的，以鼓励在美国推出BioLong(R)。因此，MC3提议继续提供SBIR第二阶段拨款(5R44HL53168-03)，以完成必要的台式和动物研究，并对制造过程进行质量系统评估，以提交IDE申请。此外，将进行第一阶段临床试验的准备工作，包括招募中心、制定研究方案和医疗报销。生物肺(R)的商业潜力是巨大的。即将到来的市场将成为移植的桥梁。长期的潜力是作为康复的桥梁，或者作为终末期肺部疾病移植的替代方案。目前，等待肺移植的患者数量超过3800人。在这些患者中，只有大约25%的人会在明年接受移植，原因是可用的捐赠者稀缺，感染性并发症，以及患者的身体不够强壮，无法在手术中存活。生物肺(R)有可能增加肺移植受者的数量，因为它将提供一种方法来稳定等待移植的患者，并为移植后提供支持，从而允许适当使用边缘器官捐赠者。这种类型的结果已经在应用左心室辅助装置支持心脏移植患者中看到。

DESCRIPTION (provided by applicant): With significant support from the NIH SBIR grant program (5R44HL53168), MC3 has successfully developed an artificial lung, called the BioLung(r). The BioLung(r) design is based on our patented, ultra-low pressure drop artificial lung technology. This device has undergone extensive bench top and animal testing during its development over the past 10 years, and will be manufactured in a commercial form ready to enter the U.S. and European regulatory process by August of 2004. Given the extensive and expensive regulatory process in the U.S., MC3 believes that it is essential to obtain an investigational device exemption (IDE) from the FDA in order to encourage the introduction of the BioLung(r) in the U.S. by way of a license agreement with a medical device distributor. As such, MC3 is proposing a continuation of a SBIR Phase II grant (5R44HL53168-03) to complete the necessary bench-top and animal studies, and quality systems evaluation of the manufacturing process to submit an IDE application. In addition, preparations for the Phase I clinical trial will be undertaken, including recruitment of centers, study protocol development, and medical reimbursement. The commercial potential for BioLung(r) is significant. The immediate market will be as a bridge to transplant. The long-term potential is as a bridge to recovery or as an alternative to transplant for end-stage lung disease. Currently, the number of patients awaiting lung transplantation exceeds 3,800. Of these patients, only about 25% will receive a transplant in the next year due to the scarcity of available donors, infectious complications, and because the patients are not physically strong enough to survive surgery. The BioLung(r) has the potential to increase the number of lung transplant recipients because it will provide a method to stabilize patients awaiting transplantation, and provide an option of support for post transplant, thereby, allowing the appropriate use of marginal organ donors. This type of outcome has been seen in the application of left ventricular assist devices in supporting patients for heart transplantation.